HBF-1000 OMRON BODY COMPOSITION ANALYZER

K963575 · Omron Healthcare, Inc. · MNW · Jun 13, 1997 · Cardiovascular

Device Facts

• Record ID: K963575
• Device Name: HBF-1000 OMRON BODY COMPOSITION ANALYZER
• Applicant: Omron Healthcare, Inc.
• Product Code: MNW · Cardiovascular
• Decision Date: Jun 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2

Intended Use

Estimation of Body Fat.

Device Story

HBF-1000 Body Composition Meter estimates body fat percentage. Device uses bioelectrical impedance analysis (BIA) to measure body composition. User stands on device; electrical current passes through body; impedance measured. Device calculates body fat based on impedance, height, weight, age, and gender inputs. Used in home or clinical settings; operated by patient or healthcare provider. Output displayed on device screen to assist in monitoring body composition and health status.

Clinical Evidence

No clinical data provided in the document; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Bioelectrical impedance analysis (BIA) technology. Device measures body impedance to estimate body fat. Form factor is a body composition meter/scale. Operates via electrical impedance measurement.

Indications for Use

Indicated for the estimation of body fat in the general population.

Regulatory Classification

Identification

An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.

Special Controls

*Classification.* Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Edward R. Siemens
Senior Vice President
Sales & Marketing
Omron Healthcare, Inc.
300 Lakeview Parkway
Vernon Hills, Illinois 60061
Dear Mr. Siemens:

Re: K963575
HBF-1000 Body Composition Analyzer
Dated: May 12, 1997
Received: May 15, 1997
Regulatory class: II
21 CFR §870.2770/Product code: 74 MNW

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Enclosure

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Page ___ of ___

510(k) Number (if known): K963575

Device Name: HBF-1000 Body Composition Meter

Indications For Use: Estimation of Body Fat.


(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K963575

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☑

(Optional Format 1-2-96)